BioIVT, a leading provider of biospecimens, research models and services for drug and diagnostic development, today announced the launch of its Good Manufacturing Practice (GMP-) grade VivoSTART™ leukopaks. Leukopaks contain concentrated white blood cells and are used to research and manufacture cell and gene therapies.
“This GMP-grade leukopak product introduction underscores BioIVT’s commitment to being a high quality, global immune cell provider,” said BioIVT CEO Dr. Richard Haigh. “BioIVT customers have always been able to scale their research up and out using our global collection network of recallable donors. With the VivoSTART leukopak launch, our customers can now transition seamlessly from research to manufacturing without compromising product integrity.”
GMP-compliant VivoSTART leukopaks will serve as the ideal starting material for allogeneic ex vivo cell therapies and other advanced therapeutic applications. BioIVT’s immune cell experts will work with customers to validate donors based on specific demographic criteria, HLA-type, or Fc receptor type, or other desired specifications. BioIVT also offers supply chain security solutions, such as reserving cells from specific donors for specific projects.
Matt Chorley, VP of Quality at BioIVT, explained: “As allogeneic cell and gene therapies continue to show promise, their successful clinical development begins with choosing a vendor for their starting material. Each therapy is unique, so our goal is to work not only as a starting material vendor, but also a quality partner and develop quality specifications that work in their individual research programs.”
BioIVT’s VivoSTART leukopak product line is supported by its FDA-registered collection site in Johnson City, Tennessee which meets all applicable US GMP/GTP standards (21 CFR 606, 1271 and 21 CFR part 11 and part 58). BioIVT’s GMP leukopaks also comply with all documented sourcing, handling, processing, storage, preserving, packaging, and product distribution procedures.
BioIVT experts will be available to discuss the company’s GMP and research use only Immune Cell Portfolio at the Cell & Gene Meeting on the Mesa, which will be held in Carlsbad, CA from October 11-13. BioIVT will also be holding a mixer event for conference attendees on the evening of Monday, October 10. Additional details are available at https://info.bioivt.com/motm-event-reg.
BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.